Dr Reddy's to launch 20 products in US in FY20

The company anticipates US FDA approval for generic Nuvaring in the first half of FY20, while the launch of generic Copaxone in the US may get further delayed as the company received additional queries from the drug regulator relating to the product, the management said.

Dr Reddy’s on May 17 said it is planning to launch 20 products in the US and aims to maintain 50 percent plus gross margin in FY20.

The company anticipates US FDA approval for generic Nuvaring, a contraceptive, in the first half of FY20.

The US launch of generic Copaxone, used in the treatment of multiple sclerosis, may get further delayed until FY21. It has received additional queries from the drug regulator relating to the product, the management said in the company’s earnings call.

Dr Reddy's is banking on generic Suboxone used in the treatment of drug addiction to boost US sales. It is expected to gather pace in the second quarter, led by conversion from innovator product to generic, it said. The uptake of Suboxone, launched in February this year has been slow.

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The company said it is litigating for the recovering bond of $72 million held against the Indivior for delaying the launch of generic version through litigation.

The company said it’s expecting the gross margins in FY20 to be over 50 percent and guided of spending around $250-300 million on R&D. The company had gross margins of 52.2 percent in FY19, while the spend on R&D stood at Rs 1,561 crore. For FY19, net profit of Dr Reddy's stood at Rs 1,880 crore on revenues of Rs 15,385 crore.

It is focusing on improving R&D productivity and already seeing signs of improved efficiency, it said.

Dr Reddy’s said it will be majorly investing in India and China to grow the business and has identified 70 products for China, and started the process of filing.

On the regulatory front, the company said it is trying to resolve the warning letter on CTO-6 active pharmaceutical ingredient plant in Srikakulam. It has been answering queries raised by USFDA and soon will be meeting with the agency to seek re-inspection, it added.

Dr Reddy’s earlier cleared inspections of Duvvada oncology injectable facility and Miryalaguda API plant, which were also mentioned in the USFDA warning letter issued in 2015.